Novavax Willing To Submit COVID-19 Vaccine Before Phase III Completed
US FDA Commissioner Hahn’s controversial statement about approval before the end of Phase III has at least one taker, which may concern public health observers.
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The move reduces the pressure on the companies to rush development, but also relieves burden on the FDA to approve a candidate too soon.
Former FDA Commissioner says agency could grant an EUA for a vaccine, but require it meet the standard for full approval, and then roll it out gradually with postmarket data collection.
Coronavirus Update: After Rumors Of Shortcut To Market, AZ Pledges To ‘Follow Science’ In Vaccine Trials
The company reiterates core values to 'follow the science' and 'put patients first' after talk of an emergency use authorization without completing Phase III trials.